drugset / Trial / NCT03315507

A Study to Assess the Safety, Tolerability, and Hemodynamic Response of PB1046 in Subjects With PAH

NCT03315507 ↗

Phase 1 Completed 3 enrolled PhaseBio Pharmaceuticals Inc.
NaSingle-groupOpen-labelTreatment

Summary

PB1046-PT-CL-0005 is an open-label, dose-titration study to assess the safety, tolerability, and hemodynamic effects of individually dose-titrated PB1046 administered by weekly subcutaneous injection for 8 weeks in adult subjects with PAH who have a permanently implanted hemodynamic monitor in the distal pulmonary artery. The primary objectives of the study are to assess the overall safety, tolerability, and hemodynamic profile of a PB1046 across an individually titrated dose range.

Timeline

Start
2017-10-20
Primary completion
2019-08-08
Completion
2019-08-08

Drugs

EvaluationDrugModalityDoseRoute
Subject PB1046 Peptide — Subcutaneous